Complaint handling, CAPA, design controls and field service run under design-history and quality-system rules that punish silent failure. That makes medtech a natural fit for fail-closed automation, and a poor fit for anything that guesses.
Read the "before" and find yours. Most medtech teams start here and find that half of what they assumed needed AI didn't.
Before
Complaints arrive by email, phone and rep, get rekeyed into the QMS, and are classified from memory. The auditor's first question has no clean answer.
After
One intake, one taxonomy, one owner per complaint type: written down and followed. The queue is visible and the audit answer is a document.
Before
Due dates live in spreadsheets, signatures are chased by email, and nothing escalates until it's late.
After
Deterministic routing, due dates and escalation on the QMS you already run. Nothing moves without a named owner; nothing goes quiet.
Before
Reportability is assessed by hand, one complaint at a time, by the few people qualified to do it, and the backlog is measured in weeks.
After
An agent drafts the classification and reportability rationale, stops below a confidence threshold, and every draft is attributed. Qualified people decide; they don't transcribe.
Before
Trends are assembled quarterly by hand, and the same root cause surfaces again in the next audit.
After
Patterns across complaints, service records and field data surface monthly. The quality owner adjusts thresholds; the change is logged by her team.
The left column is what we usually find. The right column is the same process, one level at a time, each step is paid for by the one before it.
Baseline these before anything changes. The Survey instruments them; the Pilot is measured against them.
| Metric | How to measure it | Who it moves |
|---|---|---|
| Complaint cycle time | Days from receipt to closed, median and 90th percentile | Quality, regulatory |
| Reportability decision time | Days from receipt to decision | Regulatory affairs |
| Investigation share | % of quality hours on investigation vs documentation | VP Quality |
| Audit findings on process | Findings per audit related to traceability or timeliness | Quality, board |
Every automated decision carries what it saw, what it decided and who signed.
Documentation stops eating the week.
Patterns surface monthly instead of in the next audit.
We start with what you own. None of these is a partnership we take margin on.
With complaint intake standardized. It's the step that returns hours before any software is bought, and it makes everything after it cheaper. The assessment tells you whether your process is already past that point.
Usually not at first. Most of the delay in complaint to reportability decision comes from manual hops between systems, which deterministic rules remove. An agent earns its place only where the inputs vary, and we start it read-only.
The ones you already run. We start with capability you license and nobody switched on, and we take no margin on anything we recommend. If a different tool would remove a real roadblock, you get the case and the switching cost in writing.
Bring one process. You leave knowing which level it's on, what to fix first, and whether it's worth doing anything at all.